# US 12,000,830 B2 · Serological assay for the detection of zika virus-specific antibodies utilizing overlapping peptides comprising an NS2B epitope

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- Number: US 12,000,830 B2
- Document ID: US12000830B2
- Status: Granted
- Kind: B2
- Application number: 16/466,161
- Filed: 2017-12-01
- Published: 2019-11-28
- Granted: 2024-06-04
- Earliest claimed: 2016-12-01
- Assignees: The Trustees of Columbia University in the City of New York
- Applicants: The Trustees of Columbia University In the City of New York
- Inventors: Walter Ian Lipkin; Nischay Mishra; Thomas Briese; Adrian Caciula
- Web page: https://patentgrep.com/patent/US12000830B2

## CPC

- G01N 33/56983: {Viruses}
- A61K 35/76: Viruses; Subviral particles; Bacteriophages
- C07K 7/00: Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
- C07K 14/005: from viruses
- C07K 16/06: from serum
- C07K 16/116: Togaviridae (F); Matonaviridae (F); Flaviviridae (F)
- C07K 2317/21: from primates, e.g. man
- C07K 2317/34: Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
- C12N 2770/24122: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- G01N 2333/185: Flaviviruses or Group B arboviruses, e.g. yellow fever virus, japanese encephalitis, tick-borne encephalitis, dengue
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The current invention provides compositions, methods, and kits for detecting the exposure to and infection by certain viruses. Specifically, the current invention allows for the rapid differential serological detection of exposure to, and infection by viruses. In particular, the current invention allows for the rapid serological detection of exposure to, and infection by Zika virus (ZIKV).

## Claims

### Claim 1

A method for the serological detection of an antibody to Zika virus in a sample, comprising:
a. contacting the sample with a collection of isolated non-redundant peptides specific for antibodies to Zika virus, wherein the peptides are 5 amino acids to 20 amino acids in length of the sequences set forth in SEQ ID NO: 1 or SEQ ID NOS:14-22, under conditions sufficient to allow the binding of the antibody(ies) to the peptide(s);
b. washing antibodies that have not bound to the isolated non-redundant peptides;
c. labeling bound antibodies with a detectable label; and
d. detecting formation of an antibody-peptide complex comprising said one or more peptides in the collection,
wherein formation of the complex is indicative of an antibody to an epitope of a Zika antigen being present in the sample.

### Claim 2 (depends on 1)

The method of claim 1, wherein the sample is from a subject.

### Claim 3 (depends on 2)

The method of claim 2, wherein the subject is a human female.

### Claim 4 (depends on 3)

The method of claim 3, wherein the subject is pregnant.

### Claim 5 (depends on 2)

The method of claim 2, wherein the subject is a test subject which has been administered a Zika virus vaccine or immunomodulatory agent.

### Claim 6 (depends on 2)

The method of claim 2, wherein the subject had a seropositive result on an enzyme-linked immunosorbent assay (ELISA).

### Claim 7 (depends on 1)

The method of claim 1, wherein the sample is chosen from the group consisting of nasopharyngeal aspirate, blood, cerebrospinal fluid, saliva, serum, plasma, urine, sputum, bronchial lavage, pericardial fluid, and peritoneal fluid.

### Claim 8 (depends on 1)

The method of claim 1, wherein the collection of peptides is immobilized to a solid support.

### Claim 9 (depends on 1)

The method of claim 1, wherein the detecting step comprises performing an ELISA assay.

### Claim 10 (depends on 1)

The method of claim 1, wherein the collection of peptides comprises peptides which are 12 amino acids in length.

### Claim 11 (depends on 1)

The method of claim 1, wherein the collection of peptides comprises peptides of SEQ ID NOs: 14-22.

### Claim 12

A method for the serological detection of an antibody to Zika virus in a sample, comprising:
a. contacting the sample with a collection of isolated non-redundant peptides specific for antibodies to Zika virus, wherein the peptides are 5 amino acids to 20 amino acids in length of the sequences set forth in SEQ ID NOs: 2-13 and over 50% reactive in Zika virus convalescent serum samples, under conditions sufficient to allow the binding of the antibody(ies) to the peptide(s);
b. washing antibodies that have not bound to the isolated non-redundant peptides;
c. labeling bound antibodies with a detectable label; and
d. detecting formation of an antibody-peptide complex comprising said one or more peptides in the collection,
wherein formation of the complex is indicative of an antibody to an epitope of a Zika antigen being present in the sample.

### Claim 13 (depends on 12)

The method of claim 12, wherein the collection of peptides comprises peptides 12 amino acids in length.

### Claim 14 (depends on 12)

The method of claim 12, wherein the sample is from a subject.

### Claim 15 (depends on 12)

The method of claim 12, wherein the subject is a human female.

### Claim 16 (depends on 12)

The method of claim 12, wherein the subject is pregnant.

### Claim 17 (depends on 12)

The method of claim 12, wherein the subject is a test subject which has been administered a Zika virus vaccine or immunomodulatory agent.

### Claim 18 (depends on 12)

The method of claim 12, wherein the sample is chosen from the group consisting of nasopharyngeal aspirate, blood, cerebrospinal fluid, saliva, serum, plasma, urine, sputum, bronchial lavage, pericardial fluid, and peritoneal fluid.

### Claim 19 (depends on 12)

The method of claim 12, wherein the collection of peptides is immobilized to a solid support.

### Claim 20 (depends on 12)

The method of claim 12, wherein the detecting step comprises performing an ELISA assay.